Enrollment begins on new clinical study for the first device designed specifically for the endovascular treatment of aortic arch and descending thoracic aorta lesions, while maintaining flow into a single aortic arch branch vessel.
March 3, 2017 - Baylor Scott & White The Heart Hospital – Plano is proud to be the only approved implant site in North Texas for the W.L. Gore & Associates, Inc. (Gore) GORE® TAG® Thoracic Branch Endoprosthesis (TBE) pivotal study. William Brinkman, MD, medical director, Thoracic Aortic Disease Center, Baylor Scott & White Heart – Plano is the principal investigator for the pivotal trial at this site.
The objective of the study is to determine the safety and effectiveness of the TBE device in treating lesions of the aortic arch and descending thoracic aorta (which includes dissection, trauma, or aneurysm), while maintaining flow into a single aortic arch branch vessel.
"The TBE device used in the pivotal study offers a less-invasive treatment for patients with Zone 0/1 aortic arch disease, where traditionally, surgical treatment may not have been an option," Dr. Brinkman says. "These advanced thoracic stents will allow us to treat aneurysms and dissections of the aortic arch without chest incisions."
Treatment of aortic arch disease has traditionally required complex open surgical techniques. Unfortunately, many patients are not candidates for traditional open surgery due to frailty, advanced age, and other comorbidities. The limited options for these patients is one of the reasons that the TBE is the first Gore device to receive the new FDA Expedited Access Pathway (EAP) designation and among the first medical devices to receive this designation in the U.S. This pathway is limited to certain medical devices that demonstrate the potential to address unmet medical needs for life-threatening diseases and offer a meaningful patient benefit compared to existing alternatives.
"The beautiful advantage of this device is that it uses a very successful and already established thoracic stent platform but adds a side branch component. The side branch component allows us the ability to treat complex aortic conditions in the area adjacent to the heart without the need for an additional surgical bypass to the blood vessels of the neck or arms," said William Shutze, MD, co-director, Thoracic Aortic Disease Center.
Designed for long-term durability the GORE TAG Thoracic Branch Endoprosthesis is the first off-the-shelf aortic branch device to participate in a pivotal study. With both an aortic and a side branch component, the pre cannulated device was engineered to provide perfusion to one arch vessel.
"Since 2008, nearly 3,000 patients have participated in clinical trials conducted through Baylor Scott & White Heart – Plano. In that time, we have completed more than 50 trials and have 75 active clinical trials." said Mark Valentine, president, Baylor Scott & White Heart – Plano. "We are involved with diverse clinical trials, all in the interest of providing the best possible care for our guests."
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Physicians are members of the medical staff at one of Baylor Health Care System's subsidiary, community or affiliated medical centers and are neither employees nor agents of those medical centers, Baylor Scott & White The Heart Hospital – Plano or Baylor Health Care System.